Trial Outcomes & Findings for Randomized Controlled Trial of a Patient Activation Tool in Pediatric Appendicitis (Antibiotics Alone vs. Appendectomy) (NCT NCT02110485)

Last Updated: 2019-11-19

Results Overview

Decision Self-Efficacy will be measured using the Decision Self-Efficacy Scale which measures the participant's confidence in their ability to make decisions and consists of 11 questions regarding different aspects of decision making. This will be measured 1 hour after treatment decision has been made. The scale is a 5 point scale ranging from 0-not at all confident to 4-very confident. Higher scores are better. Scoring includes summing all items, dividing by 11; and multiplying by 25. A score of 0 means "extremely low self efficacy and a score of 100 means extremely high self efficacy

Recruitment status

COMPLETED

Study phase

Target enrollment

200 participants

Primary outcome timeframe

1 hour following decision

Results posted on

2019-11-19

Participant Flow

Participant milestones

Participant milestones
Measure	Patient Activation Tool Patients and their caregivers will receive the patient activation tool in addition to standard consultation Patient Activation Tool: An interactive tablet based tool designed to (1) teach patient activation strategies; (2) provide evidence-based information about a health condition, (3) help patient/caregiver dyads recognize and clarify their own values, and (4) provide guidance in decision making and communication among those involved with the decision.	Standard Consultation Patients and their caregivers will receive standard consultation alone
Overall Study STARTED	98	102
Overall Study COMPLETED	91	83
Overall Study NOT COMPLETED	7	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Randomized Controlled Trial of a Patient Activation Tool in Pediatric Appendicitis (Antibiotics Alone vs. Appendectomy)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patient Activation Tool n=98 Participants Patients and their caregivers will receive the patient activation tool in addition to standard consultation Patient Activation Tool: An interactive tablet based tool designed to (1) teach patient activation strategies; (2) provide evidence-based information about a health condition, (3) help patient/caregiver dyads recognize and clarify their own values, and (4) provide guidance in decision making and communication among those involved with the decision.	Standard Consultation n=102 Participants Patients and their caregivers will receive standard consultation alone	Total n=200 Participants Total of all reporting groups
Age, Categorical <=18 years	98 Participants n=5 Participants	102 Participants n=7 Participants	200 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	12 years n=5 Participants	13 years n=7 Participants	12 years n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	41 Participants n=7 Participants	80 Participants n=5 Participants
Sex: Female, Male Male	59 Participants n=5 Participants	61 Participants n=7 Participants	120 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) White	88 Participants n=5 Participants	85 Participants n=7 Participants	173 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	98 Participants n=5 Participants	102 Participants n=7 Participants	200 Participants n=5 Participants
Insurance Status Private Insurance	59 Participants n=5 Participants	67 Participants n=7 Participants	126 Participants n=5 Participants
Insurance Status Medicaid	37 Participants n=5 Participants	28 Participants n=7 Participants	65 Participants n=5 Participants
Insurance Status No insurance	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 hour following decision

Outcome measures

Outcome measures
Measure	Patient Activation Tool n=98 Participants Patients and their caregivers will receive the patient activation tool in addition to standard consultation Patient Activation Tool: An interactive tablet based tool designed to (1) teach patient activation strategies; (2) provide evidence-based information about a health condition, (3) help patient/caregiver dyads recognize and clarify their own values, and (4) provide guidance in decision making and communication among those involved with the decision.	Standard Consultation n=102 Participants Patients and their caregivers will receive standard consultation alone
Decision Self-Efficacy Scale	100 units on a scale Interval 95.5 to 100.0	100 units on a scale Interval 97.7 to 100.0

PRIMARY outcome

Timeframe: 1 day from enrollment

Healthcare satisfaction will be measured at the time of discharge (average 1-2 days) using the PedsQL 3.0 Healthcare Satisfaction Generic Module- Parent Report. This survey measures the parent's satisfaction with the care their child received and measures six dimensions (information, inclusion of family, communication, technical skills, emotional needs, and overall satisfaction) using 24 items. Parents chose a score from 0-4; 0=never happy; 1=sometimes happy; 2=often happy; 3=almost always happy; 4=always happy, followed by the ability to respond "not applicable" Subscale scores are not reported If not applicable is chosen, the item is not scored nor included n the final sum. Scoring is based on a total sum for all items as well as a subscale sum for each of the 6 dimensions. Higher scores are better. Total scores range from 0-96

Outcome measures

Outcome measures
Measure	Patient Activation Tool n=98 Participants Patients and their caregivers will receive the patient activation tool in addition to standard consultation Patient Activation Tool: An interactive tablet based tool designed to (1) teach patient activation strategies; (2) provide evidence-based information about a health condition, (3) help patient/caregiver dyads recognize and clarify their own values, and (4) provide guidance in decision making and communication among those involved with the decision.	Standard Consultation n=102 Participants Patients and their caregivers will receive standard consultation alone
PedsQL 3.0 Healthcare Satisfaction Generic Module (Parent Report)	98.3 units on a scale Interval 91.7 to 100.0	99.0 units on a scale Interval 94.7 to 100.0

PRIMARY outcome

Timeframe: 1 year folow-up

Disability days will be assessed at 1 year follow-up. Disability days is a composite of inpatient hospital days, emergency department visits, primary care physician visits and all days with limited activities referable to their appendicitis.

Outcome measures

Outcome measures
Measure	Patient Activation Tool n=83 Participants Patients and their caregivers will receive the patient activation tool in addition to standard consultation Patient Activation Tool: An interactive tablet based tool designed to (1) teach patient activation strategies; (2) provide evidence-based information about a health condition, (3) help patient/caregiver dyads recognize and clarify their own values, and (4) provide guidance in decision making and communication among those involved with the decision.	Standard Consultation n=91 Participants Patients and their caregivers will receive standard consultation alone
Disability Days	5 Days Interval 2.0 to 15.0	6 Days Interval 2.0 to 11.0

SECONDARY outcome

Timeframe: 1 hour

Parent activation will be assessed with the Patient Activation Measure® (Parent-PAM®) using a version of healthy child parent PAM® adapted with permission. This 13 item scale and was derived from the short form version of the Patient Activation Measure®. The Parent-PAM® is used to assess the parent's activation in the management of their child's health. The 13 items have response options ranging from 1=strongly disagree to 4 strongly agree with an option to respond as "not applicable". A total PAM score is calculated by summing all items and dividing by the number of items answered and multiplied by 13; total scores can range from 13-52. This score is transformed to a scale ranging from 0-100 with higher PAM scores indicating higher patient activation.

Outcome measures

Outcome measures
Measure	Patient Activation Tool n=98 Participants Patients and their caregivers will receive the patient activation tool in addition to standard consultation Patient Activation Tool: An interactive tablet based tool designed to (1) teach patient activation strategies; (2) provide evidence-based information about a health condition, (3) help patient/caregiver dyads recognize and clarify their own values, and (4) provide guidance in decision making and communication among those involved with the decision.	Standard Consultation n=102 Participants Patients and their caregivers will receive standard consultation alone
Patient Activation Measure (PAM)	91 units on a scale Interval 75.0 to 100.0	100 units on a scale Interval 77.7 to 100.0

SECONDARY outcome

Timeframe: 1 year

Readmissions rates to any hospital within 1 year wil be assessed

Outcome measures

Outcome measures
Measure	Patient Activation Tool n=83 Participants Patients and their caregivers will receive the patient activation tool in addition to standard consultation Patient Activation Tool: An interactive tablet based tool designed to (1) teach patient activation strategies; (2) provide evidence-based information about a health condition, (3) help patient/caregiver dyads recognize and clarify their own values, and (4) provide guidance in decision making and communication among those involved with the decision.	Standard Consultation n=91 Participants Patients and their caregivers will receive standard consultation alone
Number of Participants Readmitted	15 Participants	15 Participants

SECONDARY outcome

Timeframe: 30 day follow-up

The PedsQL Pediatric Quality of Life Inventory is a 23 item survey with response options offered on a 5 point scale; 0= never been a problem; 1=almost never a problem; 2=sometimes a problem; 3=often a problem; 4=almost always a problem. A total score is summed for each of the 4 dimensions as well as an overall score for the entire measure. The PedsQL Family Impact Module Scales include subscales: physical functioning; emotional functioning; social functioning; cognitive functioning; communication; worry; family functioning; daily activities; and family relationships. The options for this 5-point scale range from 0= never a problem to 4=always a problem). Items are reverse-scored and high scores indicate better family functioning. A total summed score is utilized. Each subscale can be summed individually and divided by the number of items in that. Total scores for this measure range from 0-92

Outcome measures

Outcome measures
Measure	Patient Activation Tool n=71 Participants Patients and their caregivers will receive the patient activation tool in addition to standard consultation Patient Activation Tool: An interactive tablet based tool designed to (1) teach patient activation strategies; (2) provide evidence-based information about a health condition, (3) help patient/caregiver dyads recognize and clarify their own values, and (4) provide guidance in decision making and communication among those involved with the decision.	Standard Consultation n=76 Participants Patients and their caregivers will receive standard consultation alone
PedsQL Pediatric Quality of Life Inventory and PedsQL Family Impact Module Scales	88.0 units on a scale Interval 79.3 to 96.7	88.0 units on a scale Interval 81.0 to 96.7

Adverse Events

Patient Activation Tool

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Consultation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Beth Fischer

Nationwide Children's Hospital

Phone: 614-355-0338

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place